Global Study Comparing Datopotamab Deruxtecan with Rilvegostomig Versus Standard Therapy in Adults with High-risk Muscle Invasive Urothelial Carcinoma After Surgery

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining Dato-DXd with rilvegostomig as an additional treatment compared to standard care in adults with high-risk muscle invasive urothelial carcinoma MIUC who have undergone radical surgery. This Phase III trial focuses on participants with residual disease at high risk of recurrence after surgery. The study aims to see if the new combination improves disease-free survival compared to current standard treatments. Participants are randomly assigned to one of three groups Arm 1 receives Dato-DXd plus rilvegostomig intravenously every three weeks for up to one year Arm 2 receives Dato-DXd alone on the same schedule Arm 3 receives standard care, which includes nivolumab, durvalumab, or a combination of enfortumab vedotin and pembrolizumab, given intravenously at intervals ranging from every two to four weeks for up to a year. Treatment duration and dosing can be adjusted based on tolerance and investigator assessment. During the trial, participants will have visits approximately every three weeks or as per standard care schedules, depending on their assigned group, for up to 12 months of treatment. Researchers will monitor disease recurrence and survival outcomes for up to 78 months from the first participants enrollment. Assessments include clinical evaluations and disease status monitoring to measure disease-free survival and overall survival. Participants will be followed closely to assess safety and effectiveness of the treatments over this extended period.

An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC